May

2015

Cl II Nihon Kohden Remote Network Station

Company: Nihon Kohden America Inc.
Date of Enforcement Report: 5/6/2015
Class lI:

PRODUCT

Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for multiple patients within a medical facility. The device will display physiological data from up to 16 telemetry receiver/transmitters or bedside monitors and generate an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmias are detected.
Recall Number Z-1543-2015

REASON
Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.

RECALLING FIRM/MANUFACTURER
Nihon Kohden America Inc, Irvine, CA on 4/14/2015. Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
208 units

DISTRIBUTION
Nationwide

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Nihon Kohden Remote Network Station

Amy Sellers

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